Lymph Node Mapping in Patients With Endometrial Cancer

Ohio State University Comprehensive Cancer Center204 enrolled

Overview

This clinical trial studies lymph node mapping in patients with endometrial cancer. Lymph node mapping may allow for limited removal of lymph nodes in as part of endometrial cancer staging and treatment.

PRIMARY OBJECTIVE: I. To estimate the negative predictive value of pelvic sentinel lymph node (SLN) in endometrial cancer to predict nodal metastasis. SECONDARY OBJECTIVE: II. To examine the ability of sentinel lymph nodes to increase the detection of metastatic disease through ultra-sectioning and immuno-histochemical (IHC) staining by comparing IHC results and standard hematoxylin and eosin (H\&E) results. OUTLINE: Patients undergo sentinel lymph node detection using fluorescence imaging with indocyanine green solution and isosulfan blue and sentinel lymph node biopsy and detection of sentinel lymph nodes is noted in the within 30 minutes of injection of the dye, followed by full pelvic lymph node dissection and aortic lymph node dissection as indicated, and standard hysterectomy and salpingo-oophorectomy. After completion of study treatment, patients are followed up every 3 months for 2 years, every 6 months for 3 years for a total of 5 years according to the standard surveillance guidelines for endometrial cancer.

Study Type

INTERVENTIONAL

Allocation

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

204

Conditions

Endometrial Cancer

Interventions

sentinel lymph node detectionPROCEDURE

Undergo sentinel lymph node detection using fluorescence imaging with indocyanine green solution and isosulfan blue

indocyanine green solutionDRUG

Undergo sentinel lymph node detection using fluorescence imaging with indocyanine green solution and isosulfan blue

isosulfan blueDRUG

Undergo sentinel lymph node detection using fluorescence imaging with indocyanine green solution and isosulfan blue

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 85 Years

Medical Language ↔ Plain English

Inclusion Criteria: * The patient must be willing and able to provide informed consent * The patient is willing and able to comply with the study protocol * The patient has endometrial cancer and is scheduled for robotic hysterectomy and lymphadenectomy * The patient agrees to follow-up examinations out to 5-years post-treatment Exclusion Criteria: * The patient is not a candidate for robotic assisted hysterectomy and lymphadenectomy * The patient has known or suspected allergies to iodine, indocyanine green (ICG) or isosulfan blue (ISB) * The patient has hepatic dysfunction confirmed by bilirubin \> 2 x normal (based on reference values from the laboratory used by the patient)

Locations (2)

Smilow Cancer Hospital at Yale New Haven

New Haven, Connecticut, United States

Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical Center

Columbus, Ohio, United States

Outcomes

Primary Outcomes

Negative Predictive Value of Sentinel Lymph Node Prediction of Metastatic Disease

NPV is found by dividing the number of true negatives by the number of all patients without pelvic lymph node metastases. Exact 95% confidence intervals (CIs) for the proportions will be calculated.

Time frame: average of 1-14 days after the procedure when final pathologic evaluation has been completed

Secondary Outcomes

Percentage of Metastatic Cases Found Using Ultra-sectioning and IHC Staining

The percentage of metastatic cases analyzed by H\&E will be compared to those of H\&E-plus- IHC/ultrastaging using a "z-test".

Time frame: average of 1-14 days after the procedure when final pathologic evalulation has been completed

Data from ClinicalTrials.gov

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